Neoveil® Versus TachoSil® for the Treatment of Pulmonary Air Leaks Following Lung Operation

University Hospital, Basel, Switzerland46 enrolled

Overview

Postoperative prolonged air leak (PAL), referring to the passage of air from the lung parenchyma into the pleural space, is one of the most frequent postoperative complications after lung resection. To control air leak, there are two different products certified since years: TachoSil® and Neoveil®. This study is to investigate the difference of TachoSil® and Neoveil® in patients with PAL.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Prolonged Air Leak Postoperative Air Leak

Interventions

TachoSil®OTHER

topical absorbable fibrin sealant patch applied directly on the lung area with air fistula.

Neoveil®OTHER

bioabsorbable soft-tissue reinforcement material applied on the normal shape of the lung at the end of the operation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with a pulmonary air leak following open lung surgery, regardless of whether an anatomical or atypical resection was performed * Patients who are able to decide for themselves whether to participate in the study or not ( for example due to language problems, mental disorders, dementia of the participant) * Patients who are not family member or employee of the investigator Exclusion Criteria: * Inability to follow the procedures of the study, for example, due to language problems, mental disorders, dementia of the participant * Enrolment of the investigator, his/her family members, employees and other dependent persons

Locations (1)

Department of Thoracic Surgery, University Hospital Basel

Basel, Switzerland

Outcomes

Primary Outcomes

time required till air leak closure has occurred (hours)

time interval between end of the operation (closure of the skin) and air leak closure (less than 30ml on the digitalized drainage system).

Time frame: end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)

Secondary Outcomes

Incidence of air leak (binary outcome 0/1), i.e. air loss > 30ml

Incidence of air leak (binary outcome 0/1), i.e. air loss \> 30ml

Time frame: end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)

Intensity of air leak (continuous outcome, ml)

Time frame: end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)

Incidence of prolonged air leak (>10 days) (binary outcome 0/1)

Incidence of prolonged air leak (\>10 days) (binary outcome 0/1)

Time frame: assessed at 10th postoperative day

Data from ClinicalTrials.gov

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